CN101133326B

CN101133326B - Disposable immunodiagnostic test system

Info

Publication number: CN101133326B
Application number: CN200580045347.7A
Authority: CN
Inventors: 乌马·马赫什·巴布
Original assignee: INTERNAT BIO THERAPEUTIC RES I
Current assignee: INTERNAT BIO THERAPEUTIC RES I
Priority date: 2004-11-01
Filing date: 2005-11-01
Publication date: 2013-05-29
Anticipated expiration: 2025-11-01
Also published as: JP2008518215A; AP2007004015A0; BRPI0516894A; EP1815250A1; CN101133326A; WO2006047869A1; AU2005301045A1; CA2585695C; JP5364266B2; EP1815250A4; AU2005301045B2; CA2585695A1; ZA200704512B; MX2007005180A

Abstract

A disposable immunodiagnostic system tests for marker proteins in liquid sample analytes. It includes intimately contacting passage, protein, and absorbent layers. The passage layer is non-porous and has an aperture therethrough. The protein layer is porous and operatively enables immobilization of combinable proteins thereon, as well as passage of the analyte therethrough. The protein layer has an active surface area that is aligned with the passage layer aperture. The analyte is operatively introduced onto the protein layer through the passage layer aperture. In positive results, the marker proteins are operatively bound to the combinable proteins and immobilized relative to the protein layer. In negative results, the analyte operatively passes through the protein layer, and is absorbed by the absorbent layer. A housing may also be provided. The system is constructed of a combustible material that produces non-toxic by-products upon incineration, enabling ecologically responsible disposal after diagnostic use of the system.

Description

Disposable immunodiagnostic test system

Technical field

The present invention relates to the field of immunodiagnosis detection system, kit and device, more specifically, relate to a kind of easy processing (can abandon or disposable) immunodiagnosis detection system for existing at fluid sample analysis thing certification mark albumen.

Background technology

Various diagnosis detecting methods and kit have been used to clinical setting, for example immunochromatographic measurement, the multiple immunoassay diagnostics system, working sample analytical equipment and the tachysynthesis determination test band (test stripe) that exist for detection of antigen and/or antibody.Other Fast Measurement pick-up unit and method in the art can be known more or less, and these apparatus and method can be classified as a kind of in many forms, this depends on whether detected sample flows through this device, and may also depend on any such mode and/or the direction that flow.For example, pick-up unit can have dipstick (test film), flow through and/or the effluent form.

Yet sustainable existence is for needs faster and the more accurately pick-up unit of testing result being provided, also not needing being the needs of the highly qualified testing staff pick-up unit that appends training and/or for making the single analyte sample can be in that simultaneously basis is detected to detect the needs of any pick-up unit that exists in the multiple cause reagent basically for can not needing to buy extra Special Equipment.The same needs that exist for effective and wieldy and immunodiagnosis detection system, kit and/or device that can Rapid Implementation (below can with it referred to as " immunodiagnosis detection system ").

Also has a kind of exigence (it is not solved fully by aforementioned means), namely, for " instant (point of care) " and/or " field " (namely, the place of tradition outside the clinical setting is perhaps for example as exceed a part, alarm reaction work, the field hospital of intended scope and/or be used for crops or the scene of a drove of being ill temporarily) be easy to the detection system using and/or process.

In addition, exist for can be in the open air and/or be the needs of the detection system of making and/or assembling in the custom-designed manufacturing equipment of this purpose.Also exist for the needs that also can relate to than such system of low production cost and packing cost.

Have further the needs to following detection system, this detection system optionally is suitable for being used to provide qualitative results and/or quantitative result according to the characteristic of consumer taste and/or pending detection.

In the past, " immediately " immunodiagnosis system may cause serious difficulty or problem for those workmans that give this task.In the past, such device (having become the device of potentially contaminated after it is used) usually is sent to landfill yard and processes, therefore caused whole a large amount of Environmental costs and concerned issue, comprised that the pollutant of passing in time from this device may infiltrate the possibility in landfill yard and the peripheral region thereof.Due to the fact that, namely, such system usually mainly by can't be in the situation that does not produce harmful and/or poison gas safe combustion or the material (such as plastics) that burnouts consist of so that so far the landfill disposal of the part immunodiagnosis detection system of selling at present basically become essential.Detection system also is usually directed to extra transportation and processing cost and work in the processing of landfill yard.Partly because this concluding is true, field worker has been required to carry the portability waste canister that is fit to transport safely and process such potentially contaminated detection system.Such Waste disposal may relate to aseptic glassware, plastic ware, experimental ware etc., and corresponding strict sterilization sterilization and processing mode.Therefore, feel consumingly that all the time this detection system can be easy to process in simple and ecological reliably mode (for example by burning at naked light) for the needs of such detection system.

Also have the needs for the detection system of the carrier that optionally is fit to detect virus, fungi, bacterium and/or causes infecting, any or all these detections can utilize single sample to implement.

Except aforementioned, but exist for the needs that provide the visual determination testing result and/or (for example in 60 to 90 seconds) provide result's detection system within relatively in short-term interval.

Therefore, the objective of the invention is to eliminate, alleviate and/or solve one or more, relevant with prior art defective and/or shortcoming in the above-mentioned needs.

Summary of the invention

According to the present invention, disclosed a kind of immunodiagnosis detection system for detection of the existence of labelled protein in the fluid sample analysis thing.This detection system comprises the channel layer (being shaped to limit at least one by its hole) that is essentially the plane, and it forms by having the first material that is essentially the imporosity structure.This detection system also comprises protein layer, and it is comprised of the second material, this second material be suitable in operability structure (structure) so that thereon can be basically fixing in conjunction with albumen.Protein layer has and is essentially porous structure, in order to can make the fluid sample analysis thing of a part can be basically from wherein passing through.Protein layer and channel layer are the relations of close contact, in order to limit the active surface zone at protein layer, its roughly near and roughly align with the hole of channel layer.This detection system also comprises adsorbed layer, and it is comprised of the 3rd material that can adsorb at least a portion fluid sample analysis thing.Adsorbed layer and protein layer are the relations of close contact.In this operability structure, can basically be fixed on the protein layer as described above in conjunction with albumen, and fluid sample analysis thing at least one hole by channel layer is introduced on the protein layer.In the positive findings structure, labelled protein is incorporated into this and can basically be fixed in conjunction with albumen and with respect to protein layer.In the negative findings structure, the fluid sample analysis thing of at least a portion passes through protein layer basically.

According to further aspect of the present invention, the first material, the second material and the 3rd material are made of at least a combustible material that produces non-toxic by-products when burning.

According to the one side of the preferred embodiments of the present invention, detection system also can preferably include a kind of reagent, and it operationally is incorporated into the labelled protein of substantially fixing with respect to protein layer in the positive findings structure.

The one side of a preferred embodiment according to the present invention, this reagent can comprise the visable indicia thing, it operationally provides coloured indication of positive findings structure.

The one side of another preferred embodiment according to the present invention, this reagent can comprise a kind of proteinase bond.In this embodiment, detection system can preferably further comprise a kind of zymolyte, and it operationally is incorporated into the proteinase bond in the positive findings structure, and it can preferably operationally show a kind of coloured indication in the positive findings structure.

The one side of a preferred embodiment according to the present invention can be seen at least one visible part in active surface zone by the hole of channel layer.

The one side of a preferred embodiment according to the present invention, detection system can preferably further comprise at least a sealant, its basically juxtaposition between channel layer and the protein layer and between protein layer and the adsorbed layer.

According to the further aspect of the preferred embodiments of the present invention, the visible part in active surface zone can preferably include first and detect surf zone, but wherein can be in conjunction with albumen preferably with operating structure by basically fixed thereon.The visible part in active surface zone can preferably further comprise procedural contrast surface zone.This procedural contrast surface zone can preferably be adapted at showing the contrast reading in positive findings structure and the negative findings structure, correctly be used in order to operationally confirm this detection system.

According to the other aspect of the preferred embodiments of the present invention, detection system can preferably further comprise the shell that basically encapsulates channel layer, protein layer and adsorbed layer.The lower casing part of this shell is the relation of close contact with adsorbed layer.The upper housing portion of this shell and channel layer are the relations of close contact.This upper housing portion is shaped to limit at least one shell aperture (housing aperture) by it.This shell aperture is arranged with the operability fluid connecting relation with at least one hole of channel layer basically.

According to the further aspect of the preferred embodiments of the present invention, shell can preferably be made of aforementioned at least a combustible material.

The one side of a preferred embodiment according to the present invention, shell can be preferably be made of the sheathing material of the shell mechanism with the imporosity of being essentially.

According to the one side of the preferred embodiments of the present invention, at least a sealant can be preferably by juxtaposition basically between upper housing portion and the channel layer and between lower casing part and the adsorbed layer.

The further aspect of a preferred embodiment according to the present invention, shell can be preferably incorporated in the outer surface part of at least one mark indication (labeling indicium) of mark on it.This outer surface part can preferably be provided on the upper housing portion.

According to an aspect of the present invention, can can be preferably in conjunction with albumen but do not comprise not essentially and be fit to be incorporated into following protein, that is, fungi labelled protein, virus signature albumen, bacterium labelled protein, the carrier labelled protein of inducing, plant labelled protein and/or at the fluid sample analysis thing and for can be by the biosynthetic native protein of cell of substantial health in species that should analyte at least a.

The one side of a preferred embodiment according to the present invention, the visible part in active surface zone can preferably further comprise second and detect surf zone.In the operability structure, second can be fixed on second basically in conjunction with albumen detects on the surf zone.In the positive findings structure, labelled protein is incorporated into second and can and basically be fixed with respect to protein layer in conjunction with albumen.

The further aspect of this preferred embodiment according to the present invention, the visible part in active surface zone can preferably further comprise auxiliary first and detect surf zone and auxiliary the second detection surf zone.In the operability structure, can basically be fixed on first in conjunction with albumen preferably but not essentiallyly and detect surf zone and auxiliary first and detect on each of surf zone.In the operability structure, second can be fixed on second basically in conjunction with albumen preferably but not essentiallyly detects surf zone and auxiliary second and detects on each of surf zone.

The one side of a preferred embodiment according to the present invention, with respect to first detect on the surf zone can protein-bonded concentration, roughly higher concentration can basically be fixed on auxiliary first in conjunction with albumen and be detected on the surf zone.

The one side of a preferred concrete mode according to the present invention, first detect surf zone and auxiliary first detect surf zone can be together preferably but must not be defined as abstractively the first detection ring that is essentially the plane, wherein first detect surf zone and the auxiliary first each that detects in the surf zone is positioned at wherein abstractively.Similarly, second detect surf zone and auxiliary second detect surf zone can be together preferably but must not be defined as abstractively the second detection ring that is essentially the plane, wherein second detect surf zone and the auxiliary second each that detects in the surf zone is positioned at wherein abstractively.The second detection ring can be preferably but is roughly limited the scope of the first detection ring unessentially.

Similarly, the one side of a preferred embodiment according to the present invention, the first detection ring can be preferably but unessential the scope in restricted program contrast surface zone roughly.

The one side of a preferred embodiment according to the present invention, at least one hole of channel layer can be preferably but are not comprised at least two holes not essentially.The upper surface of channel layer can be preferably but is not shaped to limit roughly near these at least two holes and the recessed portion that roughly aligns with shell aperture not essentially.

The one side of another preferred embodiment according to the present invention, the surface of protein layer can be preferably but are not shaped to limit recessed portion not essentially.This recessed portion is preferably but unessentiallyly roughly near the visible part in active surface zone and roughly align with the hole of channel layer.

According to following detailed description and claims with reference to the accompanying drawings, other advantage of the present invention, feature and characteristic, and the function of the related elements of the method and structure of operation, and the economy of the combination of each several part and manufacturing will become more apparent, hereinafter will briefly describe appended accompanying drawing.

Description of drawings

According to the following drawings, the novel feature be considered to according to the characteristic relevant with its structure, mechanism, purposes and methods for using them of easy processing detection system of the present invention will be understood better, and further purpose and advantage, in the accompanying drawings, now by the mode diagram of embodiment at least one at present preferred embodiment of the present invention is described.Yet, it should be clearly understood that accompanying drawing does not need to describe in proportion and only be used for the purpose of graphic extension and description.Owing to these and other reason, be to be understood that accompanying drawing is not used in boundary line of the present invention is limited.In the accompanying drawings:

Figure 1A is the skeleton view according to the left anterior-superior part of a preferred embodiment of disposable immunodiagnostic test system of the present invention;

Figure 1B is the skeleton view of opening with the left anterior-superior part of the detection system of the Figure 1A shown in the decomposition texture, and wherein it roughly aligns with the each several part shown in the empty outline line;

Fig. 2 A is the skeleton view according to the left anterior-superior part of another preferred embodiment of the detection system that comprises shell of the present invention;

Fig. 2 B is the skeleton view of opening with the left anterior-superior part of the detection system of Fig. 2 A shown in the decomposition texture;

Fig. 2 C is the amplification diagram of the encircled 2C of Fig. 3 of will be hereinafter discussing;

Fig. 2 D is the skeleton view according to the left anterior-superior part of the different preferred embodiments of the detection system that comprises a plurality of passage layer aperture of the present invention;

Fig. 2 E is the skeleton view of opening with the left anterior-superior part of the detection system of Fig. 2 D shown in the decomposition texture;

Fig. 2 F is that the detection system shown in Fig. 2 D is along the amplification diagram (being similar to Fig. 2 C) of collimation line 2F-2F;

Fig. 3 is that the detection system of Fig. 2 A is along the cut-open view of collimation line 3-3;

Fig. 4 A is the vertical view that is similar to the further preferred embodiment of the detection system shown in Fig. 2 A according to the present invention;

Fig. 4 B is the vertical view of the detection system of Fig. 2 A;

Fig. 4 C is the vertical view of further preferred embodiment that is similar to the detection system of Fig. 2 A according to the present invention;

Fig. 4 D is the vertical view of the detection system of Fig. 2 D, shows upper housing portion and channel layer;

Fig. 4 E is the vertical view of the detection system of Fig. 2 D, shows protein layer, wherein shows shell and passage layer aperture with empty outline line;

Fig. 5 A partially opens and the skeleton view according to the left anterior-superior part of the another embodiment of detection system of the present invention shown in the decomposition texture;

Fig. 5 B is the skeleton view of left anterior-superior part of the detection system of Fig. 5 A;

Fig. 6 is the skeleton view of the left anterior-superior part of the part of another embodiment according to the present invention, shows a plurality of easy disconnection detection systems, and each is similar to the detection system shown in Fig. 2 A; And

Fig. 7 is the skeleton view of the left anterior-superior part of the part of embodiment further according to the present invention, shows a plurality of easy disconnection detection systems, and each is similar to the detection system shown in Fig. 2 B.

Embodiment

Referring now to accompanying drawing 1A, 1B, 5A and 5B, show according to the preferred embodiment for detection of there being the disposable immunodiagnostic test system 70 of labelled protein (optional alternatively be called " analyte ") in the fluid sample analysis thing (not shown, but optional alternatively be called " fluid sample ") of the present invention.Shown in Fig. 5 A the best, a preferred embodiment of detection system 70 comprises detection part 50 and the shell 60 of combination.

Shown in Figure 1A and 1B the best, shall also be noted that detection system 70 can comprise simply the detection part 50 of combination and not have shell 60.

With reference to Figure 1B, will see that further combine detection parts 50 comprise channel layer 12, protein layer 14 and the adsorbed layer 16 that is essentially the plane, its each preferably produce non-toxic by-products when burning combustible material consist of.For this reason, in other side, the detection part 50 of combination can be easy to process in the reliable mode of environment (for example by burning at naked light).

As mentioned above, channel layer 12 is essentially the plane and has hole 24 by it, and wherein this hole is limited by the corresponding inward flange 26 of channel layer 12.Although have single hole 24 by channel layer 12 at the preferred embodiment shown in Figure 1A, 1B, 5A and the 5B, but the channel layer of other embodiment (referring to for example Fig. 2 D to 2F, it will discuss in detail hereinafter) can be provided with the hole 24 more than.Channel layer 12 has the structure of the imporosity of being essentially, thereby it preferably has basically impermeable, non-sponge and nonwoven characteristic.Channel layer 12 can be preferably but is not made of the paper material (such as cardboard) of densification compression not essentially.The material of other relative stiffness (for example tree bark and/or compacting leaf material) also can be used for making up channel layer 12 of the present invention.Therefore, no matter be because the result due to its preferred fine and close compression property or the intrinsic property of its construction material or other what reason, channel layer 12 is preferably detection system 70 rigidity is provided.The thickness of channel layer 12 preferred (although not must) is between about 0.2 and 10 millimeter, wherein even preferred thickness roughly in the scope between about 2 and 4 millimeters.

Shown in Figure 1A and 1B the best, protein layer 14 is relations of close contact with channel layer 12.Protein layer 14 has the described hole 24 that roughly is close to described channel layer 12 and the active surface zone 30 of roughly align with it (such as what substantially represent by the dotted line " A " among Figure 1B).Shown in Figure 1A the best, at least a portion 31 in active surface zone 30 is preferably visible by hole 24.

Protein layer 14 can be preferably (although not must) is made of nitrocellulose, nylon and/or cellulose acetate, and in fact by being combined with on it or fixing (alternatively optional, as hereinafter to be " basically fixing ") respond thing and/or can consist of by protein-bonded any other material.Biologically, term " immobilization " and " fixing " can it has been generally acknowledged that refer to for and/or the statement with cell, organelle, enzyme or other oroteins (for example, monoclonal antibody) physics or chemically be fixed on the carrier, be retained among other material in the solid matrix and/or by film, in order to increase their stability and/or be used for realizing various other purposes.Although the operation for detection system 70 is optional, think that nitrocellulose is the effective protein binding materials that can be used for protein layer 14.The nitrocellulose membrane of suitable commercially available acquisition can be in the casting of supportive papery backing plate and for the protein layer 14 according to the preferred embodiments of the present invention.The thickness of protein layer 14 preferred (although not must) is not more than about 5 millimeters, wherein even preferred thickness roughly in the scope between about 0.5 and 2.0 millimeter.

Protein layer 14 has and is essentially porous structure, and the meaning refers to that it preferably is provided with a plurality of hole (not shown) by it.In the situation of the material of nitrocellulose membrane and some other preferred protein layers 14, although the operation for detection system 70 is optional, thinking now provides the hole of large-size that lower protein combination ability and/or capacity will correspondingly be provided in protein layer 14.As further discussing in detail hereinafter, the protein layer 14 with low protein combination ability can reduce the sensitivity of any detection that utilizes system's 70 enforcements.Nitrocellulose protein layer 14 will be preferred (although not must) has the hole of diameter dimension between about 0.1 micron and 25 microns, wherein even preferred diameter dimension roughly in the scope between about 0.4 and 2.0 micron.Think have size roughly the protein layer 14 of the hole (not shown) in above-mentioned scope improved protein combination ability can be provided.

Shown in Figure 1B the best, adsorbed layer 16 is relations of close contact with channel layer 12.Indicated as its title, adsorbed layer 16 is made of sorptive material, and this sorptive material preferably is fit at least a portion (more preferably, being extra section) of absorbing or adsorbing fluid sample analysis thing to be detected according to the characteristic of detection to be performed.Adsorbed layer 16 is preferably formed by sponge material, or in fact by absorbing or any other material of at least a portion of adsorptive liquid sample analytes (not shown) forms.For example, adsorbed layer 16 can be made of paper handkerchief and/or acetate fiber material.The thickness of adsorbed layer 16 preferred (although essential) is between about 1 to 50 millimeter, wherein even preferred thickness roughly in the scope between about 5 to 20 millimeters.Preferably, adjust adsorbed layer 16, make it adsorbable and keep three times of applying in the single testing process and the fluid sample analysis thing that amasss of polyploid more.

As mentioned above, adsorbed layer 16 is relations of close contact with protein layer 14, and protein layer 14 is relations of close contact with channel layer 12.Although the basic operation for detection system 70 is optional, preferably, channel layer 12 and protein layer 14 by means of juxtaposition basically betwixt the sealant (not shown) and keep together with the relation of described close contact.Similarly, protein layer 14 and adsorbed layer 16 can be preferably by means of juxtaposition basically betwixt identical or different sealant (not shown) and keep together with described close contact relation.Appropriate seal agent according to the present invention can be preferably but is not comprised glue and other bonding agent not essentially, and use joint seal nail, stitching and heating and/or ultrasonic sealing method, perhaps in fact comprise being suitable for guaranteeing that each

layer

12,14,16 roughly remains any other material or the technique of aforementioned close contact relation each other.In order to be easy to make, according to the present invention, think that the sealant of conventional domestic or glue just can be enough to provide sufficient sealing property.

Shown in Figure 1A and 5A the best, the detection part 50 of combination can preferably also comprise parts periphery sealing 34.Shown in Figure 1A and 5A, in the preferred embodiment of detection system 70, parts periphery sealing 34 is knitting

layer

12,14,16 each neighboring part securely.Assembly periphery sealing 34 can be by consisting of with identical or different sealant discussed above.For example, assembly periphery sealing 34 can be made of the binding material of the neighboring part that can bond to layer 12,14,16.Except above-mentioned sealant and encapsulating method, assembly periphery sealing 34 can be replacedly made by any material as described below or the material that is actually form as described below, and namely described material provides each

layer

12,14,16 physical compression (may roughly be close to their neighboring part) to keep each other the relation of close contact to guarantee them.For example, assembly periphery sealing 34 can comprise the clamping component (not shown), and it engages the neighboring part of passage 12 and adsorbed layer 16 so that all three

layers

12,14,16 that concern for close contact towards each other apply force of compression.

Shown in Fig. 5 A and 5B the best, shell 60 has encapsulated channel layer 12, protein layer 14 and adsorbed layer 16 basically, this be because they can be together preferably but be not assembled to form the detection part 50 of combination not essentially.Shell 60 can preferably include upper housing portion 10 and lower casing part 18.Upper housing portion 10 and lower casing part 18 can be preferably but are not relations of close contact with channel layer 12 and adsorbed layer 16 respectively not essentially.Preferably, upper housing portion 10 and channel layer 12 can the relation with above-mentioned close contact keep together by means of aforesaid identical or different sealant (not shown), and wherein roughly juxtaposition is betwixt for sealant.Similarly, lower casing part 18 and adsorbed layer 16 can be preferably by means of betwixt identical of juxtaposition roughly or even with the sealant (not shown) and keep together with the relation of above-mentioned close contact.

Shown in Fig. 5 B the best, shell 60 can preferably further be provided with shell edge part 36, its roughly with

housing parts

10,18 up and down in each one or more neighborings continuous.In the preferred embodiment of detection system 70, shell edge part 36 can engage the neighboring part 34 (shown in Fig. 5 B) of the detection part 50 of combination securely, but and/or each the neighboring part (such as Fig. 2 A, 2D and shown in Figure 3 and hereinafter further discuss in detail) in its

knitting layer

12,14,16.Shell edge part 36 can be by consisting of with identical or not identical sealant discussed above, comprise that above-mentioned reference part periphery seals 34 mentioned any interchangeable sealant materials, method and/or form, preferably make the relation of detection part 50 with the shell 60 maintenance close contacts of combination.

Shown in Fig. 5 A and 5B the best (and also such as Fig. 2 A, 2B, 2D, 2E and shown in Figure 3, other preferred embodiment of detection system 70 has wherein been described, as can further discussing in detail hereinafter), upper housing portion 10 is provided with the shell aperture 20 that the corresponding inward flange 22 by upper housing portion 10 that passes itself limits.Shell 60 preferably is made of the material that is essentially imporosity, and the meaning refers to be preferably the basically material of impermeable and/or nonabsorbable and/or non-textile structural.

All parts of shell 60 preferably are made of the material that produces non-toxic by-products when burning, and guarantee that better detection system 70 can be processed with the reliable mode of environment (for example by burning).Paper is a kind of preferably applicable to the material that makes up shell 60.Other similar material also can be used for according to shell 60 of the present invention, and such material can comprise fabric, nylon, silk and/or biological degradable

membrane.Housing parts

10,18 each thickness preferred (although essential) is between about 0.1 and 3 millimeter up and down, wherein even preferred thickness roughly in the scope between about 0.2 and 0.4 millimeter.

Preferably but not essentiallyly, be not suitable for detecting the size of single detection system 70 of single liquid analyte samples basically on the order of magnitude of about 20mm * 20mm * 10mm.

Shown in Fig. 5 B, the upper housing portion 10 of shell 60 preferably includes outer surface part 46, is marked with mark indication 11 on it.Preferably, this mark indication 11 can be macroscopic for the people, and can comprise bar code indication 13 and/or the literal indication 15 of serial number.In the embodiment that does not comprise shell 60, mark indication 11 can replacedly directly be marked at (not shown) on the outer surface part of channel layer 12.In any situation, mark indication 11 can be marked on the outer surface part by printing, stickup or the mode of writing.The bar code indication 13 of sequence numbering can be preferably but is not configured to follow the tracks of each detection system 70 not essentially and is used for other purpose (comprising for example quality control purpose).Similarly, literal indication 15 information and the data that can comprise about disposable immunodiagnostic test system 70 and planned use thereof, for example title of plan detection, keeping life, instructions, condition of storage, processing spec etc.Should further understand, mark indication 11 also can comprise the dedicated test system 70 of color code (not shown) to differentiate that each is dissimilar.

Shown in Fig. 5 A the best, can insert in the hollow shells 60 by detection part 50 that will combination preferably but not essentiallyly and assemble detection system 70.Shell aperture 20 can be preferably with channel layer 12 in below hole 24 are approximate vertical location (registration).Then, shell 60 can preferably be sealed by shell edge part 36 at each end place of its openend.As mentioned above, forming the material of shell edge part 36 can be identical or can not be identical with the material that seals 34 for the parts periphery.In above-mentioned mode, easily process immunodiagnosis system 70 (shown in Fig. 5 B the best) can be preferably but do not assembled fully not essentially.

Fig. 2 A to Fig. 4 E shows the preferred embodiment of the optional replacement of detection system 70, wherein, as the situation in institute's drawings attached, in possible situation, in order to make things convenient for reference, in each diagram, represent similar elements of the present invention with identical label.Identical with detection system discussed above in the embodiment of the detection system 70 shown in Fig. 2 A, 2B, 2C and Fig. 3 aspect most of, just up and down

outer shell

10,18 each include and be essentially the plane and more discrete layer segment, it is basically than the entity that more resembles pillow shown in Fig. 5 A and the 5B.

Should be appreciated that and shown in Fig. 2 B the best, shell aperture 20 is alignd with passage layer aperture 24 (substantially representing such as dotted line " B " among Fig. 2 B) basically according to the content of front.

Shown in Fig. 2 C the best, a upper surface of protein layer 14 can be preferably but is not shaped to limit recessed portion 58 not essentially, and this recessed portion 58 roughly is close to the

inward flange

22,26 of upper housing portion 10 and channel layer 12 and roughly aligns.

With reference to figure 2D to Fig. 2 F, show the replaceable preferred embodiment of detection system 70, wherein, channel layer 12 is equipped with the first hole 24a, the second hole 24b and control wells (control aperture) 24c that passes it.Shown in Fig. 2 F the best, a upper surface of channel layer 12 can be preferably but is not shaped to limit recessed portion 56 not essentially, and this recessed portion 56 roughly is close to the inward flange 22 of upper housing portion 10 and roughly aligns.

According in the present invention further optimization embodiment shown in Fig. 6 and Fig. 7, can provide disposable immunodiagnostic test system 70 with multiple test format.In such embodiment, single detection system 70 can removably connect side by side and/or have frangibility relation ground and be arranged by splitting shell perforation 38 (they can be torn by terminal user's (not shown)), the terminal user can determine the quantity of any specific or detection system 70 that intended application is required.Each detection system 70 shown in Figure 6 all can be basically with Fig. 2 A to Fig. 4 E in other place shown in those are corresponding.Similarly, the detection system of each shown in Fig. 7 70 is all can be basically corresponding with shown in Fig. 5 A and the 5B those.

As mentioned above, the various preferred embodiments of detection system 70 illustrated in the accompanying drawings all preferably but be not suitable for having labelled protein in the tracer liquid sample analytes (not shown) not essentially.The fluid sample analysis thing is the sample that detects for by this system 70, and this sample can comprise or can not comprise the labelled protein of being sought.That is to say, the fluid sample analysis thing is to treat material or component detected or that analyze, and comprises for example fluid sample matrix, serum, blood plasma, sweat, urine sample and/or comprise other aqueous extract of body substances (wherein embedding and/or be suspended with histocyte).Can be preferably but unessentially, other analyte that can utilize system 70 to detect can comprise environmental sample, for example the well water sample.Therefore, detection system 70 can preferably be suitable for detecting the existence from the labelled protein of wide variety (comprising biology, agronomy, veterinary science and/or environment source).

By means of example, in agricultural is used, described system 70 can use in conjunction with aqueous plant or leaves extract, to detect the various diseases that in banana plant, exists, for example banana bract mosaic virus (BBrMV) (such as the common banana plant disease in India, Philippine and the Sri Lankan area) and/or abaca mosaic virus (in the common banana plant disease of Philippine).

Similarly, in the veterinary science situation, described system 70 can be used to detect the various diseases in animal and/or domestic pets (in dog or cat) existence.For example, described system can be used to detect the existence of heartworm disease and/or Other diseases, for example leishmaniasis (leishmaniasis), parvovirus infections (parvo viral infection) and/or Lyme disease (lyme disease).

By means of another example, described system 70 can be preferably but also is used to detect the existence of various environmental contaminants unessentially, for example gasoline additive (such as methyl tert-butyl ether).In the situation of such gasoline additive, although and they can be commonly used to be of value to air quality by reducing motor vehicle emission, they can also have problem ground to arrive the underground water source of finally being doomed for the human consumption.

By means of further example, it is existence of the common various diseases that can be caused by many pathogen that detection system 70 also can be used for detecting for the mankind.For example, detection system 70 of the present invention can be used for detecting simultaneously the existence of the virulence factor relevant with a large amount of diseases (such as cardiovascular disease).In the situation of angiocardiopathy, virulence factor can comprise a large amount of different pathogens, for example the factor of virus, fungi and/or bacterial origin.In such detection, system 70 also can be used to detect the antibody for healthy cell label (the protein myosin of for example finding) in cardiac muscle, and/or for any antibody of the above-mentioned virulence factor of listing.

The concrete application of the detection system 70 of this paper discussion only is used for or not limiting the purposes that may use and change in conjunction with various fluid sample analysis things of detection system 70 as the example of detectability of the present invention.

Operatively, the protein layer 14 of detection system 70 will preferably have be incorporated into and/or basically fixed thereon can be in conjunction with the albumen (not shown).Within the scope of the invention, can be adhered on the surface of protein layer 14 and/or they can roughly embed wherein in conjunction with albumen.In fact, can will preferably fall within the scope of the present invention in conjunction with protein combination and/or the various different modes that are attached to protein layer 14 widely.

Operationally be incorporated into can preferably being selected especially in conjunction with albumen of protein layer 14 of detection system 70, to meet detection to be performed and/or in order to guarantee and the combination of looking for labelled protein that may in particular liquid sample analytes to be detected, exist.Such as, but be not limited to, if detection system 70 is to detect the existence of HIV1, then especially well be suitable for can substantially be fixed on the protein layer 14 in conjunction with albumen and/or its labelled protein in conjunction with HIV1.Similarly, if detection system 70 is used for detecting hepatitis C, then especially well be suitable for can substantially be fixed on the protein layer 14 in conjunction with albumen and/or its labelled protein in conjunction with hepatitis C.

As mentioned above, detection system 70 can be preferably but is not used for detecting simultaneously the virulence factor for a large amount of diseases of existence not essentially, comprise for example factor of virus, fungi and/or bacterium origin, wherein under these circumstances, can be fixed on the protein layer 14 in conjunction with albumen accordingly.That is, this protein that can comprise in conjunction with albumen the labelled protein that the fungi labelled protein, virus signature albumen, bacterium labelled protein and/or the carrier that are suitable for being bonded in the fluid sample analysis thing that may be present in detection are induced.

Should be appreciated that protein layer 14 is detection system 70 " reaction zones ".In the operations according to the instant invention structure, can preferably basically be fixed on the protein layer 14 in conjunction with albumen, and more preferably, be fixed on the active surface zone 30 and visible part 31 of protein layer 14.According to the present invention, the nitrocellulose of detection system 70 or other oroteins layer 14 can be preferably can offer terminal user's (not shown) in by situation basically fixed thereon in conjunction with albumen.Alternatively optional, can in conjunction with albumen also can be preferably when detecting or close on when detecting and be fixed on the protein layer 14.In any situation, and as mentioned above, can in conjunction with albumen preferably look for labelled protein (if being present in experimenter's fluid sample analysis thing of detection) by as adhere to or in conjunction be fixed to the upper those.

Although the operation for detection system 70 is optional, think, can preferably directly be fixed on the protein layer 14 in conjunction with albumen, usually near active surface zone 30, and more preferably in the visible part 31 in active surface zone 30.Can be fixed in the visible part 31 in active surface zone 30 with pattern, shape or the detail of design of any hope in conjunction with albumen, even after detection system 70 is assembled fully.Such as, but be not limited to, after detection system 70 assemblings, HIV1 can in conjunction with albumen can be preferably with numeral " 1 " but the visual determination form of (not shown) be fixed on the active surface zone 30, and similarly, hepatitis C can be preferably be fixed thereon with the form of letter " C " in conjunction with albumen.Certainly, any other such form can be used to user and/or the production firm of adaptive detection system 70.

According to the present invention, can can be by can substantially being fixed on the protein layer 14 in conjunction with the protein solution (not shown) applies and/or deposit on the active surface zone 30 of protein layer 14 in conjunction with albumen, for example, spray, physically utilize pipette and/or this can be interspersed on the appointed area of nitrocellulose membrane or other oroteins layer 14 in conjunction with protein solution by ink-jet, then so that can be by absorbing and/or capillarity be adsorbed on the protein layer 14 in conjunction with albumen.

Therefore, be to be understood that, before detecting, when detection system 70 is assembled into the operability structure, for detection of can preferably being selected and/or be fixed on the protein layer 14 with the form of any useful pattern in conjunction with albumen of the multiple different labelled proteins in the fluid sample analysis thing, basically in the regional extent in active surface zone 30.

In the situation in the active surface zone 30 that can basically be fixed in conjunction with albumen protein layer 14, labelled protein (not shown) in the fluid sample analysis thing, in the part design purposes of discussing hereinafter, can allow to become and basically be fixed with respect to protein layer 14.

Shown in Fig. 4 A and 4B the best, preferably, the user can see active surface zone 30 by the hole 24 of shell aperture 20 and channel layer.In the embodiment shown in Fig. 4 A and the 4B, active surface zone 30 comprises that first detects surf zone 32 and procedural contrast surface zone 28.In the operability structure, be fixed on can basically be fixed on the first detection surf zone 32 in conjunction with albumen on the protein layer 14.Procedural contrast surface zone 28 is suitable for showing the contrast reading in positive findings structure (shown in Fig. 4 A and 4B) in detection system 70 and the negative findings structure (not shown), is correctly used, processes and/or store in order to preferably confirm it.

More specifically, and shown in Fig. 4 A and 4B the best, if detection system 70 is correctly used, processed and/or store, then contrasting reading can preferably produce in procedural contrast surface zone 28 and show.The contrast reading can be preferably but do not adopt not essentially color or can corresponding on the active surface zone 30 that operationally is fixed on protein layer 14 can protein-bonded pattern other indication form, as mentioned above.

Lack the contrast reading in the procedural contrast surface zone 28 and can show preferably that any detection that utilizes detection system 70 to implement may be invalid.Do not need to be present in according in the detection system of the present invention although should be appreciated that procedural contrast surface zone 28 (strictly saying), preferably exist.

If the qualitative labelled protein that utilizes system 70 to implement single type detects, then can be preferably but detect surf zone 32 in mode shown in Fig. 4 A with respect to first not essentially and do not arrange in procedural contrast surface zone 28.

Alternatively optional, if utilize system 70 to implement the quantitative mark Protein Detection, then can be preferably but be positioned at the approximate centre position in active surface zone 30 unessentially shown in Fig. 4 B in procedural contrast surface zone 28.In Fig. 4 B, active surface zone 30 can preferably further comprise the first auxiliary detection surf zone 32a.Identical can preferably be fixed on to being operated property first in conjunction with albumen and detect surf zone 32 and auxiliary first and detect surf zone 32a upper (although preferably but unessentially with variable concentrations).For example, with respect to first detect on the surf zone 32 can protein-bonded concentration, roughly higher concentration can be fixed on auxiliary the first surveyed area 32a basically in conjunction with albumen.

Similarly, and shown in Fig. 4 C the best, if the user wishes to utilize individual system 70 at the substantially same a plurality of labelled proteins that exist that detect temporally, then procedural contrast surface zone 28 can be preferably but essential status in the approximate centre position in active surface zone 30.Shown in Fig. 4 C, active surface zone 30 can comprise extraly that second detects surf zone 33, wherein second group of different can operatively being fixed thereon in conjunction with the albumen (not shown).Can preferably be selected and/or be adjusted in conjunction with albumen for second group, with detection exist be different from described (first group) can protein-bonded labelled protein.Similarly, second group can be fixed on the protein layer 14 in the mode of any useful pattern in conjunction with albumen.

Detect the surf zone 33 except the first detection surf zone 32, auxiliary first detects surf zone 32a and second, shown in Fig. 4 C, active surface zone 30 also can comprise the surperficial 33a of auxiliary the second detection.Identical can in conjunction with the albumen preferred operations be fixed on second and detect surf zone 33 and auxiliary the second detection surf zone 33a (although preferably but unessentially with different concentration).For example, with respect to second detect on the surf zone 33 can protein-bonded concentration, roughly higher concentration can be fixed on auxiliary the second surveyed area 33a basically in conjunction with albumen.

Shown in Fig. 4 C the best, the first detection surf zone 32 and auxiliary the first detection surf zone 32a can be preferably but are limited abstractively together the first detection ring 40 that is essentially the plane not essentially.The first each that detects that surf zone 32 and auxiliary first detects surf zone 32a preferably but be not positioned at wherein abstractively not essentially.In such structure, can be preferably but basically do not drawn a circle to approve not essentially in the first detection ring 40 in procedural contrast surface zone 28.

The second detection surf zone 33 and auxiliary the second detection surf zone 33a also can be preferably but are limited abstractively together the second detection ring 42 that is essentially the plane not essentially.The second each that detects that surf zone 33 and auxiliary second detects surf zone 33a preferably but be not positioned at wherein abstractively not essentially.In such embodiment, shown in Fig. 4 C the best, the second detection ring 42 can be preferably but this upper delineation first detection ring 40 of essential ground.

Alternatively optional, the first detection surf zone 32, auxiliary first detects surf zone 32a, second and detects surf zone 33, assists the second detection surf zone 33a and procedural contrast surface zone 28 can limit abstractively together various structures, for example various other concentric and/or non-concentric geometry.Certainly, other geometric configuration can form, and for example comprises different a plurality of concentric shape.

In the embodiment of another design of the present invention, first and/or second detects

surf zone

32,33 can comprise the imitation surf zone.More specifically, basically be fixed on first and/or second and detect can be by the synthetic native protein of the cell biological of the substantial health in the fluid sample analysis thing and/or the species of this native protein are provided in conjunction with albumen on the

surf zone

32,33.

The embodiment of the detection system 70 shown in Fig. 4 D and the 4E may need some other explaining.In this embodiment, and as mentioned above (that is, usually corresponding to the discussion of above Fig. 2 D to 2F), channel layer 12 is formed with the first and

second hole

24a, 24b and the control wells 24c by it.As can be according to the consideration of Fig. 2 E and 4E and best appreciated, the first hole 24a becomes " A " with the first detection ring 40 general alignment, the second hole 24b roughly aligns with the second detection ring 42, and control wells 24C roughly aligns with the procedural contrast surface zone 28 on protein layer 14.

Now the various embodiments shown in are with reference to the accompanying drawings described the purposes of detection system 70.Yet the discussion that should be appreciated that following relevant purposes also can be preferably but usually is not applicable to not have diagram to describe not essentially but can falls into other interior embodiment of the scope of the invention.

In typical the detection, apply and/or the tracer liquid sample analytes before, first lavation buffer solution preferably joins in the detection system 70 by the shell aperture 20 of upper housing portion 10, with the visible part 31 in wetting active surface zone 30 on protein layer 14, and allows to be absorbed.This lavation buffer solution is preferably but not essentiallyly as at the sealer that also is not fixed with any zone on can protein-bonded active surface zone 30, in order to provide inactive protein (for example to clean calmodulin binding domain CaM 44, as in Fig. 4 A and 4B, seeing), preferably prevent thus label and/or add on it from other albumen of fluid sample analysis thing indiscriminately.

Then, the fluid sample analysis thing can preferably utilize pipette etc. to be introduced by the shell aperture 20 of detection system 70.Shell aperture 20 and passage layer aperture 24 are that operability flows and is communicated with so that the fluid sample analysis thing can be preferably at least one hole 24 by channel layer 12 be deposited on the active surface zone 30 of protein layer 14.The fluid sample analysis thing can be introduced with the amount that preferred (although not must) be enough to cover visible part 31 by shell aperture 20 with being operated.

As mentioned above, the labelled protein that exists in the detection system 70 tracer liquid sample analytes of the present invention.In the positive findings structure and shown in Fig. 4 A to 4E the best, the application of detection system 70 preferably demonstrates the labelled protein of looking for and actually exists in this fluid sample analysis thing.In the positive findings structure, will preferably be incorporated into from one or more labelled proteins of fluid sample analysis thing can be in conjunction with albumen and basically be fixed with respect to the active surface zone 30 of protein layer 14.

Comprise simultaneously at analyte in the situation of the first and second target label albumen, and comprise simultaneously that in active surface zone 30 first and second detect in

surf zones

32,33 the further situation, first and second detect

surf zones

32,33 can preferably have the first and second labelled proteins that are bonded to respectively it in the positive findings structure.

As mentioned above, in the situation that can comprise in conjunction with albumen native protein (described native protein is fixed in the positive findings structure on the simulation surf zone basically), labelled protein can preferably be incorporated into native protein and basically be fixed with respect to protein layer.

On the contrary, in the negative findings structure, the application of detection system 70 preferably is not presented at and has any labelled protein in the fluid sample analysis thing.In negative findings structure (not shown), at least a portion and preferred most of and/or basically whole fluid sample analysis thing basically by protein layer 14, do not adhere to simultaneously any fixing thereon can be in conjunction with albumen.

In any case, and no matter whether partly because gravity or in another kind of power (for example, inertial force, it can be in centrifugal middle generation) impact, the fluid sample analysis thing of a part can preferably substantially perpendicularly pass detection system 70, and/or cross protein layer 14, away from its inlet point.

Preferably, the fluid sample analysis thing of q.s is incorporated on the protein layer 14, basically is fixed (in the positive findings structure) or be not fixed (in the negative findings structure) with respect to protein layer 14 in order to guarantee that any target label albumen that is contained in wherein becomes.

Protein layer 14 aforementioned is essentially porous structure preferably can make the fluid sample analysis thing of a part from wherein passing through.Comprising predetermined substance (such as whole blood), piarhemia (lipaemic) and/or may need further clarification or the fluid sample analysis thing that amplifies may pass through in size is filtered less than about 5～6 microns hole in the protein layer 14 the situation, such fluid sample analysis thing can be preferably but is not clarified before detection and/or fragmentation not essentially.The fluid sample analysis thing that can detect in the situation that does not have further clarification and/or amplify can preferably comprise for example serum, blood plasma, urine, sweat and/or juice.Other can be preferably by filtering and/or the centrifugal aqueous extract of being clarified also can form a part of utilizing in the analyte that detection system 70 detects.

After this, the reagent of one or other necessary amount can be preferably adds with the preferred amount of the visible part 31 that covers active surface zone 30.This reagent is selected especially and/or is regulated, operatively to be bonded to any labelled protein that basically is fixed with respect to protein layer 14 in the positive findings structure.

In a specific embodiment of the present invention, this reagent (not shown) can preferably include the visable indicia thing, its specific bond to stick to be fixed on the protein layer 14 can protein-bonded any label albumen the time, provide to show and/or confirm that detection system 70 is in the coloured indication in the positive findings structure.Visable indicia thing (not shown) can comprise any or multiple in the various materials, for example radioactive isotope material, fluorescent material, UV absorbing material and/or coloring matter.Coloured visable indicia thing can comprise colloidal-carbon bond, collaurum bond, dyeing latex beads material etc.

Preferably, for quantitatively be nanogram to the analyte of femtogram, the amplification by enzyme conjugates may be essential.The situation of can be preferably amplifying by enzyme conjugates can comprise, for example, the IgE in anaphylodiagnosis detects and/or for the detection of drug abuse, industry and environmental contaminants, plant disease, hormone, cancer label, Inflammation Marker etc.

In the situation of use these and/or other quantitative analysis thing, aforementioned agents can comprise proteinase bond (not shown).As with the same according to other reagent used in the present invention, the proteinase bond is selected especially and/or is regulated, operatively to be incorporated into any labelled protein of basically having been fixed with respect to protein layer 14 in the positive findings structure.

At this moment, then can preferably an other identical or different lavation buffer solution be joined active surface zone 30, with preferably but do not wash any unconjugated material off not essentially.Here, can allow lavation buffer solution to be absorbed in the protein layer 14.

Comprise in aforementioned agents under the situation of proteinase bond that the zymolyte (not shown) can then preferably be added.After this, the user waits for one suitable period (may in about 10～60 seconds scope), within this period, will offer an opportunity for zymolyte, operatively to be incorporated into the proteinase bond in the positive findings structure.Proteinase bond and zymolyte are selected and/or regulate together, show and/or confirm that detection system 70 is in the coloured indication in the positive findings structure operatively to show.In this embodiment of detection system 70, an other lavation buffer solution can preferably add by shell aperture 20, and as mentioned above, before reading result, allow this other lavation buffer solution can be substantially perpendicularly and away from its enter detection system 70 inlet point cross and a plurality of layers by this detection system.

All substances as described below preferably (although unessentially) pass protein layer 14, caught, catch and/or adsorb finally to be adsorbed layer 16, described material is can be by not adhering to (for example adhere to or in conjunction with) in can becoming with respect to protein layer 14 material fixing and that may comprise any excessive labelled protein in conjunction with albumen of being fixed thereon.

After this, may need many other lavation buffer solutions, and/or preferably apply described many lavation buffer solutions in addition with the background of the visible part 31 of removing protein layer 14, in order to clearer and more definite testing result reading is provided.

Briefly, and normally say, fluid sample analysis thing (not shown) can be preferably at least one hole 12 by the channel layer 12 of combine detection parts 50 be introduced on the protein layer 14.No matter whether be subject to the impact of gravity or some other power, the fluid sample analysis thing passes protein layer 14, then enters in the adsorbed layer 16.

After using disposable immunodiagnostic test system 70, it can preferably carry out drying, and afterwards, it can be processed with the reliable processing mode of ecology (for example by burning).

Although the operation for detection system 70 is optional, it has been generally acknowledged that channel layer 12 is tightr and more impermeable, the possibility of the side diffusion of the fluid sample analysis thing that then adds is just lower.

When assembling detection system 70 (wherein shell aperture 24 becomes " B " with channel layer 12 general alignment), allow the fluid sample analysis thing in application, to pass detection system 70.

Although not essential to the present invention, but think, the upper housing portion 10 of detection system 70,

layer

12,14,16 and/or lower casing part 18 preferably should be assembled with the relation of close contact each other and/or with non-loose fit relation, in order to the integration of improvement is provided for detection system 70.Although not essential to the present invention, but further think, detection system 70 can work effectively, as long as each layer of assembling is positioned with the relation of enough close contacts, thereby make the fluid sample analysis thing of adding enter the inlet point of detection system 70 away from it, then under the effect of gravity and/or other similar power, substantially vertically pass detection system.

Although the basic operation for detection system 70 is optional; but usually still think; the use of each

layer

10,12,14,16,18 close contact relation and gap and/or periphery sealing can make the fluid sample analysis thing substantially vertically pass away from its inlet point; and/or pass one or more in a plurality of

layer

12,14,16 of detection system 70, wherein any excessive material is preferably absorbed by adsorbed layer 16.

Utilize single detection system, detection existence and that basically carry out simultaneously for detection of a plurality of labelled proteins of single fluid sample analysis thing can provide significant advantage.When applying than (may need in addition on a plurality of detection systems) of the independent detection of 4 of corresponding enforcements or appropriate number and corresponding contrast, these advantages can preferably include the time of always implementing faster and lower material cost.

It is simple and quick to use detection system 70 will preferably use for the user, and provide quick and pin-point accuracy and effective testing result, not needing to buy extra Special Equipment does not simultaneously need being the training that highly qualified testing staff appends yet.As mentioned above, it is used and preferably can also make the single analyte sample detect any existence in a plurality of virulence factors on simultaneously basis basically.Detection system 70 can preferably be used to clinical scenarios, instant situation and/or open-air situation.In fact, detection system 70 preferably can be in the open air and/or the particular design manufacturing equipment that is used for this purpose made and/or assembled, and similarly, it preferably also relates to lower production and packing cost.Detection system 70 preferably optionally is suitable for providing qualitative and/or quantitative result, and this depends on user's preference and/or the characteristic of detection to be performed.

Except all were above-mentioned, detection system 70 can preferably be easy to simple and ecological reliably mode is processed, for example by the burning on naked light.As mentioned above, detection system 70 can preferably optionally be suitable for detecting the infection that virus, fungi, bacterium and/or carrier are induced.At last, detection system 70 preferably provides the testing result of visual judgement and/or the result within relatively in short-term interval.

Certainly, in the situation that does not deviate from the spirit and scope of the present invention, in the Design and manufacture according to the embodiment of disposable immunodiagnostic test system 70, can use other change and variation.Such as, but be not limited to, the shell 60 of detection system 70 and/or each

layer

12,14,16 can be configured to various shapes, for example square, rectangle, circle and/or sphere.

Similarly, except the first and second above-mentioned

detection surf zones

32,33, detection system 70 can be provided with a plurality of detection surf zone (not shown).In such embodiment, the visible part 31 in active surface zone 30 can further comprise a plurality of auxiliary detection surf zones, and it is configured to various geometric configuratioies also capable of being combinedly.

In addition, although the upper surface of channel layer 12 and protein layer 14 can be shaped to limit their separately recessed

portions

56,58, channel layer 12 and protein layer 14 too can each limit separately projection or the part of such other shaping.

In addition, mark indication 11 modes that can print, paste or write to be not limited to thereon are marked on upper housing portion 10 or the channel layer 12.

In addition, although only having described, top description has a shell aperture 20, for each detection system 70 other shell aperture (not shown) that can have a plurality of minutes.

In addition, the unit of disposable immunodiagnostic test system can be arranged with " multi-packaging (multiple packs) ", or removably connect or easily broken open relation (that is, to be different from Fig. 6 and the representational relation form that removably connects shown in Figure 7) is arranged with any such other that the user wishes.

Similarly, disposable immunodiagnostic test system 70 can be assembled in the situation that does not have upper housing portion 10, and in such embodiment, it can comprise at least channel layer 12 (may have some on its outer surface mark indication 11 of mark), protein layer 14, adsorbed layer 16, low housing parts 18 and shell lateral section 36.

Similarly, can only remove lower casing part 18, this will be so that disposable immunodiagnostic test system 70 will comprise upper housing portion 10 at least, channel layer 12 (guarantee that shell aperture 20 and the hole 24 in the channel layer 12 arrange with substantially vertically aligned relation), protein layer 14, adsorbed layer 16 and shell lateral section 36.

In addition, although the Fast Measurement that detection system 70 may be described as be under the form of flowing through hereinbefore in some cases detects, it also can be replaced as being configured under the effluent form.

Detection system 70 discussed above is preferably easily processed and the good immunodiagnosis detection system of cost efficient, and it can be used for existing in tracer liquid sample analytes or the matrix one or more labelled proteins.Because the present invention can be used for detecting a plurality of labelled proteins in single detection, and can be preferably by using single fluid sample analysis thing to be implemented, so just preferably reduced the stand-by period before can obtaining the result.

Although think that the present invention mainly is as the immunodiagnosis system, it also can be manufactured into for detection of various labelled proteins and may be present in other such material in tissue cultivation fluid, plant extracts, seed extract, soil extract thing and/or water and other aqueous extract.

As mentioned above, can be preferably processed in the reliable and cheap mode of ecology according to disposable immunodiagnostic test system 70 of the present invention, for example by burning or burning in naked light.

Than present obtainable other analyte detection apparatus, described disposable immunodiagnostic test system 70 can preferably have the cost of lower production and relative processing.

Claims

1. one kind for detection of the disposable immunodiagnostic test system that has multiple labelled protein in the fluid sample, and described detection system comprises:

The channel layer on plane, it is made of the first material that is the structure of imporosity, and is shaped to limit at least one by its hole;

Protein layer, it is by being shaped to make first and second can consist of in conjunction with proteopexy the second material thereon, described protein layer has can make a part of described fluid sample can pass through its porous structure that is, and wherein said protein layer and described channel layer be the relation of close contact in order to limit the active surface zone at described protein layer, described active surface region adjacent and align with the described hole of described channel layer;

Adsorbed layer, its 3rd material by the described fluid sample that can adsorb at least a portion consists of, and described adsorbed layer and described protein layer are the relation of close contact;

Wherein, at least one hole of described channel layer is shaped to receive described fluid sample; And

Described fluid sample is introduced on the described protein layer by described at least one hole of described channel layer, so that in the positive findings structure, at least a labelled protein in the described multiple labelled protein is incorporated in to described can being fixed in conjunction with albumen and with respect to described protein layer, and so that in the negative findings structure, the described fluid sample of at least a portion can be in conjunction with albumen and be not attached to fix on the described protein layer any described by described protein layer;

Wherein, can be observed described active surface zone by described at least one hole, described active surface zone comprises a plurality of the first surveyed areas, a plurality of the first surveyed areas are disposed in the first ring with first diameter, and a plurality of the second surveyed areas, a plurality of the second surveyed areas are disposed in the second ring with Second bobbin diameter, described Second bobbin diameter is greater than described the first diameter, wherein, described first can be in conjunction with proteopexy at described the first surveyed area, and described second can be in conjunction with proteopexy at described the second surveyed area, thereby when described fluid sample comprises this type of labelled protein, can be in conjunction with protein combination with described labelled protein and described first and second;

Wherein, each in described the first material, described the second material and described the 3rd material is made of one or more different combustible materials respectively, and each in the wherein said combustible material is respectively the material that produces non-toxic by-products when burning.

2. detection system according to claim 1, wherein, described active surface zone also comprises control zone.

3. detection system according to claim 2, wherein, described control zone is arranged on the center of the described first ring that comprises described a plurality of the first surveyed areas.

4. detection system according to claim 1, further comprise a kind of reagent, wherein, when at least a in the described multiple labelled protein is bonded to described first and second when can be protein-bonded at least a, described reagent is bonded to the described labelled protein that is fixed on the described active surface.

5. detection system according to claim 4, wherein, described reagent comprises the visable indicia thing, its provide at least a in the described multiple labelled protein be bonded to described first and second can protein-bonded at least a and described first and second can the protein-bonded at least a coloured indication that is fixed to described protein layer.

6. detection system according to claim 5, wherein, described visable indicia thing comprises the dyeing latex beads.

7. detection system according to claim 5, wherein, described visable indicia thing comprises the collaurum bond.

8. detection system according to claim 5, wherein, described visable indicia thing comprises the colloidal-carbon bond.

9. detection system according to claim 4, wherein, described reagent comprises the proteinase bond, and wherein said detection system further comprises when at least a in the described multiple labelled protein and is bonded to the described first and second zymolytes that functionally are incorporated into described proteinase bond when can be protein-bonded at least a.

10. detection system according to claim 9, wherein, when at least a in the described multiple labelled protein is bonded to described first and second when can be protein-bonded at least a, described zymolyte shows coloured indication.

11. detection system according to claim 1, wherein, when at least a in the described multiple labelled protein is bonded to described first and second when can be protein-bonded at least a, the described fluid sample of a part is by described protein layer.

12. detection system according to claim 1 comprises that further at least a juxtaposition is between described channel layer and the described protein layer and the sealant between described protein layer and the described adsorbed layer.

13. detection system according to claim 1, wherein, the visible part in described at least one hole of passing through in described active surface zone further comprises procedural contrast surface zone; And wherein, described procedural contrast surface zone is suitable for being bonded to described first and second when can be protein-bonded at least a when at least a in the described multiple labelled protein, and when there not being labelled protein to be bonded to described second can be in conjunction with in the albumen any time, show the contrast reading, correctly used in order to functionally confirm described detection system.

14. detection system according to claim 13, wherein, described procedural contrast surface zone is suitable for further confirming that described detection system is correctly processed and stored.

15. detection system according to claim 13, wherein, the thickness of described channel layer is between 0.2mm and 10mm.

16. detection system according to claim 15, wherein, the thickness of described channel layer is between 2mm and 4mm.

17. detection system according to claim 13, wherein, described the first material comprises tightly compacted paper material.

18. detection system according to claim 17, wherein, described paper material is paper board material.

19. detection system according to claim 13, wherein, described the first material comprises the tree bark material.

20. detection system according to claim 13, wherein, described the first material comprises compacting leaf material.

21. detection system according to claim 13, wherein, the thickness of described protein layer is not more than 5mm.

22. detection system according to claim 21, wherein, the thickness of described protein layer is between 0.5mm and 2mm.

23. detection system according to claim 13, wherein, described the second material is shaped to limit the hole by it, and wherein the bore dia in each described hole is between 0.1 micron and 25 microns.

24. detection system according to claim 23, wherein, described bore dia is between 0.4 micron and 2.0 microns.

25. detection system according to claim 13, wherein, described the second material comprises nitrocellulose material.

26. detection system according to claim 13, wherein, described the second material comprises the acetate fiber material.

27. detection system according to claim 13, wherein, described the second material comprises nylon material.

28. detection system according to claim 13, wherein, the thickness of described adsorbed layer is between 1mm and 50mm.

29. detection system according to claim 13, wherein, described the 3rd material comprises sponge material.

30. detection system according to claim 29, wherein, described sponge material comprises towel material.

31. detection system according to claim 29, wherein, described sponge material comprises the acetate fiber material.

32. detection system according to claim 13, further comprise the shell that encapsulates described channel layer, described protein layer and described adsorbed layer, the lower casing part of wherein said shell is that the relation of close contact and upper housing portion and the described channel layer of described shell are the relation of close contact with described adsorbed layer, wherein said upper housing portion is shaped to limit at least one by its shell aperture, and wherein said shell aperture is arranged with the mobile relation that is communicated with of operability with described at least one hole of described channel layer.

33. detection system according to claim 32, wherein, described shell is made of described at least a combustible material.

34. detection system according to claim 33, wherein, described shell is made of the sheathing material that has for the shell mechanism of imporosity.

35. detection system according to claim 34, wherein, each in described upper housing portion and the described lower casing part has the described shell mechanism of imporosity that is.

36. detection system according to claim 32, wherein, at least a sealant is collocated between described upper housing portion and the described channel layer and between described lower casing part and described adsorbed layer.

37. detection system according to claim 32 wherein, can be observed the described visible part in described active surface zone by described shell aperture.

38. detection system according to claim 32, wherein, the indication of at least one mark is marked on in the outer surface part of the outer surface part of described channel layer and described shell at least one.

39. described detection system according to claim 38, wherein, described mark indication is marked on the outer surface part of described shell.

40. described detection system according to claim 39, wherein, described outer surface part is provided on the described upper housing portion.

41. described detection system according to claim 38, wherein, described mark indication comprises the bar code indication.

42. described detection system according to claim 38, wherein, described mark indication comprises the literal indication.

43. detection system according to claim 32, wherein, each thickness of described upper outer shell and described lower outside shell is between 0.1mm and 3mm.

44. described detection system according to claim 43, wherein, each thickness of described upper outer shell and described lower outside shell is between 0.2mm and 0.4mm.

45. detection system according to claim 1 wherein, describedly can comprise the albumen that is fit to be bonded to the fungi labelled protein in conjunction with albumen.

46. detection system according to claim 1 wherein, describedly can comprise the albumen that is fit to be bonded to virus signature albumen in conjunction with albumen.

47. detection system according to claim 1 wherein, describedly can comprise the albumen that is fit to be bonded to the bacterium labelled protein in conjunction with albumen.

48. detection system according to claim 1 wherein, describedly can comprise the albumen that is fit to be bonded to the labelled protein that carrier induces in conjunction with albumen.

49. detection system according to claim 1 wherein, describedly can comprise the albumen that is fit to be bonded to the plant labelled protein in conjunction with albumen.

50. detection system according to claim 13, wherein, the described visible part in described active surface zone comprises auxiliary first surface zone; And wherein, in the operability structure, wherein, the described fluid sample of at least a portion is by described protein layer, and described first can be fixed on described first in conjunction with albumen detects on surf zone and described the auxiliary first each that detects in the surf zone.

51. described detection system according to claim 50, wherein, can protein-bonded concentration with respect to detecting described on the surf zone described first, described first of higher concentration can be fixed on described auxiliary first in conjunction with albumen and detect on the surf zone.

52. described detection system according to claim 50, wherein, described first detects surf zone and described auxiliary first detects the first detection ring that surf zone is defined as the plane together, and wherein said the first detection surf zone and described the auxiliary first each that detects in the surf zone are positioned at wherein.

53. 2 described detection systems according to claim 5, wherein, described the first detection ring limits the scope in described procedural contrast surface zone.

54. detection system according to claim 1, wherein, the described visible part in described active surface zone comprises that further auxiliary first detects surf zone and auxiliary the second detection surf zone; And wherein, in the operability structure, wherein the described fluid sample of at least a portion is by described protein layer, described first can be fixed on described first in conjunction with albumen detects on surf zone and described the auxiliary first each that detects in the surf zone, and described second can be fixed on described the second detection surf zone and described the auxiliary second each that detects in the surf zone in conjunction with albumen.

55. 4 described detection systems according to claim 5, wherein, described first detects surf zone and described auxiliary first detects the first detection ring that surf zone is defined as the plane together, and wherein said the first detection surf zone and described the auxiliary first each that detects in the surf zone are positioned at wherein; Wherein, described second detects surf zone and described auxiliary second detects the second detection ring that surf zone is defined as the plane together, and wherein said the second detection surf zone and described the auxiliary second each that detects in the surf zone are positioned at wherein; And wherein, described the second detection ring limits the scope of described the first detection ring.

56. detection system according to claim 1, wherein, described second detects surf zone comprises the simulation surf zone, wherein said second can comprise native protein in conjunction with albumen, and described native protein can carry out biosynthesizing by at least a cell for healthy in the species of described fluid sample and the cell that is provided as health; Wherein in the operability structure, wherein the described fluid sample of at least a portion is by described protein layer, described native protein is fixed on the described simulation surf zone, so that in described positive findings structure, at least a in the described multiple labelled protein is incorporated into described native protein and is fixed with respect to described protein layer.

57. detection system according to claim 32, wherein, described channel layer comprises at least two holes, and wherein, the upper surface of described channel layer is shaped to limit recessed portion, the upper surface of wherein said channel layer has recessed crooked, and wherein said recessed portion is close to described at least two holes and aligns with described shell aperture.

58. detection system according to claim 13, wherein, the upper surface of described protein layer is shaped to limit a recessed portion, the upper surface of wherein said channel layer has recessed crooked, and wherein said recessed portion is close to the described visible part in described active surface zone and aligns with the described hole of described channel layer.